Quality Engineer I

Prolaio; Chicago (IL); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Performance bonus

Equity

Health coverage (medical, dental, and视

Job summary

Prolaio, based in Chicago, seeks a Quality Engineer I to support production activities including Quality Control for components, in‑process and finished goods inspection, and transfer of products from Design to Production. This hybrid role reports to the Director, QMS, within Regulatory, Quality, and Clinical Development Operations.

You will ensure supplier quality, perform finished goods inspections, support environmental monitoring, and assist investigations to close complaints, driving

Qualifications

• Bachelor’s degree preferred, or at least 4 years of work experience in Medical Device or Pharmaceutical production environments.
• Experience with ISO 13485 and CFR Part 820.
• Working knowledge of regulatory inspections/audits.

Responsibilities

• Ensures suppliers for components and services that may impact product quality are formally qualified and documented as such.
• Perform quality inspections of finished goods and device history records, and release goods if accepted.
• Support environmental monitoring activities.
• Work with Design and Production teams to ensure the successful transfer of products and processes from Design to Production.
• Support Complaint process by organizing investigations, if required, to ensure timely completion and documentation.
• Perform monitoring and measurement activities, reporting regularly to the Director, QMS, and to Management via Management Review processes.

Skills

Regulatory inspections

Critical thinker

Independent

Team collaboration

Education

Bachelor’s degree preferred

4+ years in medical device/pharma production

ISO 13485 knowledge

CFR Part 820 knowledge

Job description

Prolaiobelieves that continuous learning and collaboration can make a significant difference in how heart care is administered. We are creating smarter ways to address heart disease and heart risks by uniting patients, care teams, and researchers on a secure, technology‑enabled platform that drives clinical innovation and offers a path toward better patient outcomes.

This is precision cardiology, and we know it’s within reach.

What Will You Do?

The Overview

The Quality Engineer I is responsible for supporting production activities including Quality Control activities for components and suppliers, in‑process and finished goods inspection and release, and the transfer of products/processes from Design to Production. This role reports to the Director, Quality Management Systems working on the Regulatory, Quality, and Clinical Development Operations Team. This is a hybrid role based in our Chicago office.

The Specifics

• Ensures suppliers for components and services that may impact product quality are formally qualified and documented as such.
• Perform quality inspections of finished goods and device history records, and release goods if accepted.
• Support environmental monitoring activities.
• Work with Design and Production teams to ensure the successful transfer of products and processes from Design to Production.
• Support Complaint process by organizing investigations, if required, to ensure timely completion and documentation.
• Perform monitoring and measurement activities, reporting regularly to the Director, QMS, and to Management via Management Review processes.

Why Prolaio?

• Impactful Work: You will join the fight against heart failure (HF)and hypertrophic cardiomyopathy (HCM) with the goal of extending and saving the lives of our patients while also being at the forefront of changing the healthcare industry through technology.
• Innovative Environment: You will be part of an organization doing something that’s never been done before.
• Professional Growth: You will join a growing team and have a substantial impact on our daily and future operations with the opportunity to continuously learn and grow.
• Collaborative Team: You will be part of a team of collaborative, curious, and committed individuals focused on the collective good, inclusiveness, scientific excellence, and advancing digital health for cardiology.

Who You Are?

Experience and Education

• Bachelor’s degree preferred, or at least 4 years of work experience in Medical Device or Pharmaceutical production environments.
• Experience with ISO 13485 and CFR Part 820.

Technical Skills and Practice

• Working knowledge of regulatory inspections/audits.

Additional Qualifications

• Passionate about what you do and excited about contributing your skills to enable better healthcare through technology.
• Humble, kind, and keen to receive and act on feedback, excited to help your teammates, and celebrate the success of your team.
• Can work independently with minimal supervision and proactively identify and mitigate future challenges.
• Area critical thinker and creative problem solver who can collaborate effectively with individuals internally and externally.
• Meaningful Compensation: Competitive salary, performance bonus, and equity so you can share in what we build.
• Great Health Coverage: Medical, dental, and vision plans with multiple options and strong company contributions.
• Family‑First Benefits: Paid parental leave, caregiver leave, and support for growing families.

As set forth in Prolaio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.